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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1972-1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to OECD TG 401. For Justification for read-across see chapter 1 of the chemical safety report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute oral toxicity after single application. Test performed before OECD and GLP guidelines. Important aspects (14 day-postobservation time) in line with current OECD guidelines.
GLP compliance:
no
Remarks:
performed before GLP guidelines
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides
EC Number:
271-756-9
EC Name:
Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides
Cas Number:
68607-24-9
IUPAC Name:
68607-24-9

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst
- Age at study initiation: no data
- Weight at study initiation: 82-104 g (mean 93 g )
- Fasting period before study: 16 h
- Housing: in plastic cages
- Diet (e.g. ad libitum): Standard Altromin R, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 %
- Amount of vehicle (if gavage): dependent on dose, not constant
- Justification for choice of vehicle: not given

MAXIMUM DOSE VOLUME APPLIED: 50 ml/kg
Doses:
800 mg/kg
1250 mg/kg
2000 mg/kg
3200 mg/kg
5000 mg/kg
No. of animals per sex per dose:
10 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing once per week
- Necropsy of survivors performed: unclear from report
- Other examinations performed: body weight, no further information
Statistics:
LD50 was calculated using Probit analysis

Results and discussion

Preliminary study:
No sex differences were observed in preliminary study, therefore only females were used in the main study
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
3 190 mg/kg bw
Mortality:
The following number of deaths were observed per dose group:
dose (mg/kg) -- number of death animals -- number of total animals
800 -- 0 -- 10
1250 -- 0 -- 10
2000 -- 1 -- 10
3200 -- 5 -- 10
5000 -- 10 -- 10
Clinical signs:
not reported
Body weight:
body weights are reported but results were not analysed or commented
Gross pathology:
unclear if done

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 in female Wistar rats after a single oral application of the surrogate substance was 3190 mg/kg bw.
Executive summary:

Acute oral toxicity of a supporting substance was determined in a study similar to OECD TG 401 (pre-GLP, RL2). The LD50 in female Wistar rats after a single oral application of the supporting substance was 3190 mg/kg bw.